Kornimate/medical-research-clean huggingface dataset:
oral supplementation of gangliosides to treat a rare metabolic disorder

Conditions: GM3 Synthase Deficiency

Summary: the purpose of this pilot project is to see if a supplemental form of dietary gangliosides can serve as a potential treatment for the rare metabolic condition called ganglioside gm3 synthase deficiency.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gm3 synthase deficiency exclusion criteria: -
education impact on rehabilitation of hospitalized patients with pneumonia and covid-19

Conditions: Pneumonia Due to COVID-19

Summary: the planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed covid-19.

the planned group size is 60 patients diagnosed with pneumonia and confirmed covid-19. the given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error. eligible patients will be randomly divided into two groups: a study group (30 patients) undergoing pulmonary rehabilitation supplemented with an education program, and a control group (30 patients) undergoing conventional pulmonary rehabilitation. patients of both groups will be included in a 14-day rehabilitation program (monday to saturday). treatments and therapies will be continued for a maximum of three hours daily. the program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. patients from the study group will additionally undergo daily education using an original brochure containing information about self management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. the test will be performed two times: before the start of rehabilitation and after completing the rehabilitation program. the patients' condition and the rehabilitation effects will be assessed using the following measures: * vital capacity (voldyne 5000) * oxygen saturation (pulse oximeter) * acid-base balance (gasometry) * fatigue (modified borg scale) * physical performance (sit-to-stand test) * dyspnea assessment (mrc dyspnea scale) * anxiety and depression (hads scale) * activities of daily living (barthel scale)

Eligibility criteria:
inclusion criteria: * hospitalization due to pneumonia due to covid-19 * positive sars-cov-2 pcr test * independence in in-bed sitting position with lower extremities placed on the floor * age 40 y.o. to 70 y.o. * no additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator) * informed, voluntary consent to participate in research. exclusion criteria: * hospitalization due to pneumonia with negative sars-cov-2 pcr test * unstable medical condition hindering performing the examination * age under 40 y.o. and over 70 y.o. * cognitive deficits impairing the ability to understand and execute commands * concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state. * failure to complete a 14-day rehabilitation program * lack of informed, voluntary consent to participate in research

Keywords: pulmonary rehabilitation covid-19 pneumonia patients' education
a phase i study of rgt-419b in patients with hr-positive, her2-negative advanced breast cancer or other solid tumors

Conditions: Breast Cancer; Advanced Solid Tumor

Summary: this is a phase 1 dose escalation and dose expansion phase i study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of rgt-419b as monotherapy in chinese patients with hr+/her2- advanced/metastatic breast cancer and other advanced solid tumors.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; subjects with hr+/ her2- advanced or metastatic breast cancer are preferred. * estimated life expectancy of at least 12 weeks exclusion criteria: * presence of visceral metastases with severe organ dysfunction * known active hepatitis b or c infection * prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage * history of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study
docetaxel in combination with gvax ® immunotherapy versus docetaxel and prednisone in prostate cancer patients

Conditions: Prostate Cancer

Summary: the primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the gvax® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. patients may have had up to one prior non-taxane chemotherapy treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate * metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy * detectable metastases * ecog performance status ≤2 (performance status of 3 if due to bone pain) * any gleason score * only one prior treatment with systemic chemotherapy * no prior treatment with gene therapy * no prior immunotherapy for prostate cancer * taxane naïve * experiencing cancer-related pain

Keywords: advanced prostate cancer hrpc prostate cancer metastatic hormone-refractory gvax chemotherapy taxotere docetaxel prednisone vaccine allogeneic cells
mil62 combined with lenalidomide versus lenalidomide for patients with rituximab refractory follicular lymphoma

Conditions: Follicular Lymphoma and Marginal Zone Lymphoma

Summary: this phase iii trial aims to compare the efficacy and safety of mil62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with follicular lymphoma (fl) and refractory to rituximab. the study randomized patients with a 1:1 ratio to receive either mil62 plus lenalidomide or lenalidomide.


Eligibility criteria:
inclusion criteria: 1. adult patients, \>=18 years of age; 2. patients with either histologically documented cd20-positive fl, who grade 1, 2 or 3a 3. evidence of refractory to rituximab 4. eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 5. at least one bi-dimensionally measurable nodal or tumor lesion defined by ct scan as: greatest transverse diameter \> 1.5 cm and a short axis ≥ 10mm 6. adequate hematologic function 7. life expectancy \>5 years 8. able and willing to provide written informed consent and to comply with the study protocol exclusion criteria: 1. evidence of refractory to lenalinomide 2. central nervous system lymphoma 3. patients with progressive multifocalleukoencephalopathy (pml) 4. prior use of any antibody therapy(except for rituximab ) within 3 months of study start 5. prior use of any anti-cancer vaccine 6. prior administration of radiotherapy 42 days prior to study entry 7. prior administration of chemotherapy 28 days prior to study entry 8. history of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix 9. history of severe allergic or anaphylactic reactions to monoclonal antibody therapy 10. known hypersensitivity to thalidomide or lenalidomide 11. regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than nhl at a dose equivalent to \< 20 mg/day prednisone 12. any serious active disease or co-morbid medical condition (such as new york heart association class ii or iv cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision) 13. infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c(including hbsag,hbcab positive with abnormal hbv dan or hcv rna ) 14. pregnant or lactating females
to compare the ear of duochrome test with +1 blur test based refraction for identification of re in different ages

Conditions: Refractive Errors

Summary: the comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains underexplored in current ophthalmic research. while the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not been thoroughly investigated.

this study aims to evaluate the efficacy, accuracy, and reliability of the duochrome test in identifying refractive errors, including myopia, hyperopia, and astigmatism, across various ages. refractive errors, including myopia, hyperopia, and astigmatism, are leading causes of visual impairment, requiring precise diagnostic tools. the duochrome test utilizes chromatic aberration to refine prescriptions, whereas the +1 blur test assesses spherical correction accuracy.

Eligibility criteria:
inclusion criteria: * age between 18 to 60 years old. * both genders. * those who have refractive error. * patients with no history of prior eye surgery. * no active eye diseases affecting visual acuity, such as cataracts or retinal disorders. * ability to cooperate with both the duochrome test and +1 blur test. exclusion criteria: * patients with severe visual impairment or neurological conditions affecting vision. * patients with nystagmus or conditions that could interfere with reliable testing. * age below 18 year and above 60 year excluded * those patients who don't show their consent."
the study on the therapeutic effect and mechanism of transcutaneous acupoint electrical stimulation in female

Conditions: Dysmenorrhea

Summary: the goal of this clinical trial is to investigate the use of teas on female patients with dysmenorrhea. the main questions it aims to answer are: questions 1：effect of teas on dysmenorrhea questions 2：mechanism of teas in treatment of dysmenorrhea participants will wear teas devices to treat dysmenorrhea during menstruation the participants in the control group were treated with oral medication for dysmenorrhea

dysmenorrhea is a common female disease, with an incidence about 20-40% in female, affecting the living quality of the patients. the treatment of dysmenorrhea usually includes hormone drugs to suppress ovulation, and oral non-steroidal anti-inflammatory drugs to relieve pain, but symptoms would relapse after drugs withdrawal. while long-term use of these drugs may cause endocrine disorders, even affect the normal preparation of pregnancy. recent studies have shown that dysmenorrhea is related to many factors such as immune and neuroendocrine changes. transcutaneous electric acupoint stimulation (teas) is a new therapeutic method derived from traditional acupuncture therapy. in this method, the electrode placed on the surface of the skin of acupoints is used to guide the stimulating current into the body and stimulate the acupoints to achieve the goal of treatment, and can effectively relieve the pain of patients by replacing the traditional mechanical stimulation of hand-twisting needles. the aim of this study is to treat dysmenorrhea in women with teas, and to observe the therapeutic effect of teas, at the same time, prostaglandins, pain-related factors and immune-related factors were detected in dysmenorrhea women before and after treatment to study the mechanism.

Eligibility criteria:
inclusion criteria: 1. there are symptoms of dysmenorrhea, the duration is more than or equal to 6 months； 2. regular menstruation, menstrual cycle 21 \~ 35 days, menstrual period 3 \~ 7 days. exclusion criteria: 1. dysmenorrhea caused by abnormality and obstruction of reproductive tract； 2. preparing for pregnancy or being pregnant； 3. endometriosis or adenomyosis with surgical indication； 4. taking nsaids within one month or receiving immunosuppressive therapy within three months； 5. implantation of pacemaker or other implanted medical electronic devices； 6. high frequency surgical equipment, artificial heart and lung, medical shortwave and microwave therapeutic apparatus were used； 7. scarring or skin damage at the site of irritation； 8. refused to sign the informed consent form.

Keywords: dysmenorrhea acupuncture teas
puerarin effects on alcohol drinking

Conditions: Alcohol Abuse

Summary: this research is designed to assess the impact of pretreatment with puerarin (npi-031g), a major ingredient in the plant kudzu, on alcohol drinking. hypothesis: short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Eligibility criteria:
inclusion criteria: * moderate to heavy alcohol drinkers (20+ drinks per week) exclusion criteria: * alcohol dependence or treatment-seeking drinkers * other drug abuse or dependence * psychiatric disorders
the synchronized trial on expectant mothers with depressive symptoms by omega-3 pufas (synchro)

Conditions: Pregnancy; Depression

Summary: the present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

maternal depression can have a significant harmful influence on both mothers and children. considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (pufas) supplementation in reducing depressive symptoms, omega-3 pufas may provide a safe strategy. the investigators evaluate efficacy and safety of omega-3 pufas for pregnant women with depressive symptoms. (participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)

Eligibility criteria:
inclusion criteria: 1. pregnant women aged 20 years or older 2. between 12-24 weeks gestation 3. a japanese conversational ability in japan site or a mandarin conversational ability in taiwan site to understand the scope of the present trial and to provide written consent for study participation 4. planned to take assessments after childbirth 5. an edinburgh postnatal depression scale (epds) score is 9 or more 6. to have good physical health judged by obstetricians. exclusion criteria: 1. history and current suspicion of psychosis or bipolar i disorder or substance-related disorder or eating disorder or personality disorder 2. serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment 3. difficult to expect a normal birth (ex: fetal malformation etc.) 4. having a history of bleeding disorder such as von willebrand's disease 5. regular treatment with aspirin or warfarin within the last 3 months 6. a smoking habit of ≥40 cigarettes per day 7. regular treatment with ethyl icosapentate or regular consumption of omega-3 pufa supplements within the last 3 months 8. a habit of eating fish as a main dish ≥4 times per week.

Keywords: pregnancy depression omega-3 fatty acids
nasal intermittent positive pressure ventilation in newborn infants with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome

Summary: the submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(nippv) vs ncpap in newborn infants with respiratory distress syndrome.

nasal intermittent positive pressure ventilation (nippv) is similar to ncpap, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. nippv is safe and effective, and already in use as an alternate "standard" therapy. nevertheless, nippv has never been used in chinese babies. the submitted trial is the first prospective, randomized trial comparing nippv vs ncpap in newborn infants with respiratory distress syndrome.

Eligibility criteria:
inclusion criteria: 1. newborn infants with birth weight \>500 gm. 2. gestational age \>24 completed weeks. 3. intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support. 4. no known lethal congenital anomaly or genetic syndromes. 5. signed parental informed consent. exclusion criteria: 1. considered non-viable by clinician (decision not to administer effective therapies) 2. life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis) 3. infants known to require surgical treatment 4. abnormalities of the upper and lower airways 5. neuromuscular disorders 6. infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube

Keywords: rds infant, newborn nippv cpap
efficacy study of "go on" in magnetic resonance imaging (mri) improvement in osteoarthritis (oa) knee

Conditions: Osteoarthritis

Summary: oa knee is a common degenerative diseases of the joint. * there are many methods to treat this condition. * hyaluronic acid is one of the recomended treatment of oa knee. * there is no any study on mri change after injection hyaluronic acid. * the hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .

this will be the phase iii randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with oa of the knee joints. randomization will be stratified by kellgren-lawrence(kl) grade (garde2 or 3), by subjects x-ray. a total of 60 subjects are planed for enrollment in this study. the study will be conducted over approximately 52 weeks.

Eligibility criteria:
inclusion criteria: * subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * ambulatory non pregnant females and males 40-\<80 years of age. * subjects who withdraw pain medication or nutritional supplements for symptom relief for oa hand for a total of at least 30 days before screening visit 0. * pain at or below 40 mm on a 100 mm vas in the index knee joints. * a documented diagnosis of oa of the knee joint, or meeting american college of rheumatology (acr) clinical criteria for classification of idiopathic (primary) oa for at least 6 months prior to screening. * subject has been documented radiographic evidence of oa of the knees from the screening visit radiograph of grade 2 or 3 according to kellgren and lawrence radiographic grading. * subject has no any contraindication for mri * subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment. exclusion criteria: * subjects with history of hypersensitivity to hyaluronate. * subjects with skin lesion at the knee joint. * a history of knee surgery within 6 months prior to screening v0. * significant prior injury to the knee joint within 12 months prior to screening v0. * disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint. * treatment with other drugs potentially affecting bone or cartilage metabolism as described below: * chronic systematic corticosteroids * diacerin or glucosamine treatment within the last 12 months.

Keywords: hyaluronic acid, oa knee, mri
personalized assessment of client experiences

Conditions: Mental Disorder in Adolescence

Summary: the purpose of this study is to compare two clinical approaches to youth mental health care.


Eligibility criteria:
inclusion criteria: 1. male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics. 2. the treating clinician is participating in the study and determines that measurement-based care (mbc) is appropriate for the youth. 3. if the family consents to complete additional research measures, one parent and/or primary caregiver must be available and willing to participate in all study assessments. 4. adolescent and at least one parent/guardian are able to complete all study procedures in english or spanish. exclusion criteria: * no other exclusion criteria
effectiveness of an apn-led self-management program in patients in the first year after renal transplantation

Conditions: Kidney Transplantation; Rental Transplantation

Summary: the aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.

renal transplant recipients have to integrate preventive behaviours into their everyday lives. from the literature it is known that patients can only partially adhere to the recommended behaviours. an evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence. the aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation. the specific aims of this study are: 1. compare differences in weight gain between subjects in the ig (intervention group) and in the cg (control group). 2. compare differences in the amount of physical exercise between subjects in the ig group and the cg. 3. compare differences in self-reported medication adherence between the subjects of the ig group and the cg. secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the ig group and the cg will be compared. design: randomised controlled trial, not blinded setting and time: the study will take place at the nephrology clinic, university hospital zürich, from 1 may 2012 through 31 april 2015. variables and measurement: physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. body weight, height, waist to hip ratio and body composition (bcm fresenius) will be measured at the nephrology clinic. physical activity will be measured with the pedometer stepwatchtm. intervention

Eligibility criteria:
inclusion criteria: * received a kidney or a kidney-pancreas transplant in the university hospital zürich exclusion criteria: * unstable psychiatric disorder * cognitive impairment * multi-organ transplantation with lung * liver or heart * illiteracy * not able to speak and understand german

Keywords: weight self-management exercise